Ranibizumab

Generic Name
Ranibizumab
Brand Names
Byooviz, Cimerli, Lucentis, Susvimo, Ranivisio, Rimmyrah, Ximluci
Drug Type
Biotech
Chemical Formula
-
CAS Number
347396-82-1
Unique Ingredient Identifier
ZL1R02VT79
Background

Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment directed against human vascular endothelial growth factor A (VEGF-A), which is a glycoprotein implicated in the pathophysiology of age-related macular degeneration. Ranibizumab is used to treat various ocular disorders with abnormal growth of blood vessels, such as neovascular (wet) age-related macular degeneration. The development of ranibizumab first began after bevacizumab, another anti-VEGF anticancer drug, was discovered to inhibit neovascularization and used in the off-label treatment of neovascular age-related macular degeneration for intravenous injection. In order to improve drug delivery to the target organ, ranibizumab is available for intravitreal use.

Ranibizumab was initially approved by the FDA in 2006 and by the European Commission (EC) in 2007. It is marketed under the brand names LUCENTIS and SUSVIMO. BYOOVIZ, a biosimilar of LUCENTIS, was approved by Health Canada in March 2022, making it the first and only biosimilar drug of ranibizumab available in Canada. In August 2022, other biosimilars CIMERLI and RAIVISIO were approved by the FDA and EC, respectively.

Indication

Ranibizumab injection for intravitreal use is indicated to treat Neovascular (wet) Age-related Macular Degeneration (AMD), macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.

Ranibizumab injection for for intravitreal use via ocular implant is used to treat Neovascular (wet) Age-related Macular Degeneration (AMD) in patients who have responded to at least two intravitreal injections of a VEGF inhibitor.

Associated Conditions
Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), Macular Edema, Myopic Choroidal Neovascularization, Neovascular Age-Related Macular Degeneration (nAMD)
Associated Therapies
-

Ranibizumab Therapy for Choroidal Neovascularization (CNV) Asociated With Angioid Streaks

Phase 1
Withdrawn
Conditions
Interventions
First Posted Date
2009-11-18
Last Posted Date
2012-07-02
Lead Sponsor
University of Illinois at Chicago
Registration Number
NCT01015495

Macular EpiRetinal Brachytherapy Versus Lucentis® Only Treatment (MERLOT)

First Posted Date
2009-11-03
Last Posted Date
2020-12-07
Lead Sponsor
King's College Hospital NHS Trust
Target Recruit Count
363
Registration Number
NCT01006538
Locations
🇬🇧

Essex County Hospital, Colchester, Essex, United Kingdom

🇬🇧

Ashford William Harvey Hospital, Willesborough, Kent, United Kingdom

🇬🇧

Royal Devon and Exeter Hospital, Exeter, Devon, United Kingdom

and more 21 locations

Intravitreal Ranibizumab for Vitreous Hemorrhage Due to Proliferative Diabetic Retinopathy (N)

First Posted Date
2009-10-16
Last Posted Date
2016-08-26
Lead Sponsor
Jaeb Center for Health Research
Target Recruit Count
261
Registration Number
NCT00996437
Locations
🇺🇸

Sarasota Retina Institute, Sarasota, Florida, United States

🇺🇸

Retina Consultants of Southwest Florida, Fort Myers, Florida, United States

🇺🇸

Carolina Retina Center, Columbia, South Carolina, United States

and more 63 locations

Comparison of Intravitreal Ranibizumab and Macular Grid-pattern Laser for Treatment of Diabetic Macular Edema

First Posted Date
2009-10-14
Last Posted Date
2009-10-16
Lead Sponsor
Szeged University
Target Recruit Count
50
Registration Number
NCT00994799
Locations
🇭🇺

University of Szeged, Medical and Pharmaceutical Center, Department of Ophthalmology, Szeged, Hungary

🇭🇺

Csolnoky Ferenc County Hospital Dept of Ophthalmolgy, Veszprem, Hungary

🇭🇺

Semmelweis University Department of Ophthalmology, Budapest, Hungary

Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema

First Posted Date
2009-10-06
Last Posted Date
2012-10-18
Lead Sponsor
Novartis
Target Recruit Count
396
Registration Number
NCT00989989
Locations
🇨🇳

Novartis Investigative Site, Taipei, Taiwan

🇨🇳

Novartis Investigational Site, Shanghai, China

Combination of Ranibizumab and Verteporfin Therapy in Neovascular Age-related Macular Degeneration

First Posted Date
2009-08-27
Last Posted Date
2016-04-22
Lead Sponsor
Novartis Korea Ltd.
Target Recruit Count
10
Registration Number
NCT00967213
Locations
🇰🇷

Dept. of Ophthalmology, KyungHee Medical Center, #1 Hoegi, Dongdaemun-gu, Seoul, Korea, Republic of

Intravitreal Ranibizumab for the Treatment of Choroidal Neovascularization in Ocular Histoplasmosis Syndrome

First Posted Date
2009-08-10
Last Posted Date
2009-08-10
Lead Sponsor
Retina Associates of Kentucky
Target Recruit Count
20
Registration Number
NCT00955630
Locations
🇺🇸

Retina Associates of Kentucky, Lexington, Kentucky, United States

Effect of Intravitreal Ranibizumab Injection With Retinal Vein Occlusion (RVO)

Phase 3
Completed
Conditions
First Posted Date
2009-07-21
Last Posted Date
2016-09-29
Lead Sponsor
Novartis Korea Ltd.
Target Recruit Count
40
Registration Number
NCT00942864
Locations
🇰🇷

Dept. of ophthalmology, Kyung Hee University Medical Center, Seoul, Korea, Republic of

Lucentis in Advanced Macular Degeneration

Phase 2
Completed
Conditions
Interventions
First Posted Date
2009-05-12
Last Posted Date
2015-06-29
Lead Sponsor
Steven R. Sanislo
Target Recruit Count
20
Registration Number
NCT00896779
Locations
🇺🇸

Stanford University School of Medicine, Stanford, California, United States

🇺🇸

California Pacific Medical Center, San Francisco, California, United States

Trabeculectomy With Mitomycin C Associated With Sub-conjunctival Injection of Ranibizumab

Not Applicable
Completed
Conditions
Interventions
First Posted Date
2009-05-04
Last Posted Date
2014-04-10
Lead Sponsor
Maisonneuve-Rosemont Hospital
Target Recruit Count
242
Registration Number
NCT00892398
Locations
🇨🇦

Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada

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